Medical Devices Expert Witnesses in Illinois

Pulmonary Critical Care Medicine, Critical Care Medicine - Medical Management, Medical Utilization & Location of Care, Fraud & Abuse, Compliance, Medical Necessity, Medical Devices, Pharmacy Management, Genomics & Personalized Health, Insurance Reviews of Plan Benefits, Insurance Clinical Policy Reviews, Long Term Acute Care & Long Term Care,

Triple Board Certified physician executive/consultant, (Board Certified in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine), with vast experience in medical necessity and utilization review. Over 12 years of experience in national insurance and payer companies. Has served as Medical Director for Aetna, Blue Cross Blue Shield Association, and interim CEO for Next Level Health Partners. Consultation services to companies and manufactures in various areas, (pharmacy, genomics, medical devices, medical management, utilization, etc.), regarding healthcare medical necessity, compliance and educational issues. Fraud and Abuse. Government plans: Medicare & Medicaid. Private insurers all plans: HMO, PPO, Specialty networks. Expert reviews and medical litigation support performed. Sub-specialty medical reviews in Pulmonary and Critical Care Medicine. Current license: Illinois; New Mexico; Oklahoma; Kentucky; New Mexico ...

Medical Devices, Biomedical Engineering - FDA, Medical Devices, FDA Compliance, FDA law, FDA Inspections, FDA medical device regulation, FDA medical device labeling, FDA regulation of clinical trials, FDA approval of medical devices. Medical Device Recalls, Medical Device Complaints, FDA Inspections

A recognized expert on the FDA regulation of Medical Devices. Experience as an expert witness involving medical device firms and FDA requirements regarding approvals, recalls, complaint investigations, and labeling. Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular device. Serve as an expert witness for cases involving FDA regulation compliance for medical devices. Regularly perform webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, a ...